This study is a proof of principal, to evaluate a safety and efficacy of a prototype suprachoroidal retinal implant.
Retinal visual prostheses are currently in early development as an intervention to improve functional vision in people who have become blind from retinal degenerative eye disease. This study follows on from an initial proof of concept study (n=3) between 2012 and 2014, and will test a second-generation retinal prosthesis device, which has the ability to be used outside of the laboratory environment (i.e. is fully implantable).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Prototype wide view suprachoroidal retinal prosthesis
Centre for Eye Research Australia
Melbourne, Victoria, Australia
Number and severity of device related serious adverse events (SAEs)
The safety of the surgical implantation assessed by the number and severity of serious adverse events (SAEs) compared to other retinal prosthesis.
Time frame: 2 years
Efficacy - visual response
The ability to generate a visual response accessed via repeatable threshold measurements of visual perception.
Time frame: 2 years
Visual Function and Functional Vision
Visual function and Functional Vision will be scored from performance on a range of acuity, orientation and mobility, and activities of daily living tasks. Outcome measures include: 1. Grating visual acuity: record the grating acuity level and average response time. 2. Square localization: response error and response time is measured. 3. Motion detection: response error and response time is measured. 4. Table top task: locate and identify objects on a table. Accuracy rates and response times will be recorded. 5. Doorway detection task: to find doorway target. Task time and accuracy of door touch will be recorded. 6. Obstacle avoidance task: task time and number of collisions is recorded. 7. Functional Low Vision Observer Rated Assessment (FLORA): this assessment tool Is used to evaluate participant functional vision and mobility.
Time frame: 2 years
Quality of life - IVI - very low vision validated questionnaire
Quality of life will be assessed via survey and self-report. The Functional Low Vision Observer Assessment (FLORA) is a questionnaire that will be used to measure participants changes in participant daily living experiences.
Time frame: 2 years
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